Trial Outcomes & Findings for ModPG3 Adult/Ped ISO 81060-2:2018 Study Protocol (NCT NCT05654714)
NCT ID: NCT05654714
Last Updated: 2025-11-19
Results Overview
BP readings for all subjects will be calculated separately for systolic and diastolic blood pressure. At least three paired blood pressure values shall be taken for each subject. ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
TERMINATED
152 participants
Day 1 (up to 1 hour)
2025-11-19
Participant Flow
Participant milestones
| Measure |
Blood Pressure Readings
The study will be conducted in 2 parts.
* Part 1 will test subjects using the ModPG3 Investigational device with the SureBP algorithm enabled.
* Part 2 will test subjects using the ModPG3 Investigational device with the StepBP algorithm enabled.
The study requires three observers. The first two observers take auscultatory readings that are averaged to use as reference blood pressures. The third observer operates the ModPG3 investigational device and records the readings for that device.
The two clinicians taking reference readings will be blinded to each other's readings and to the investigational device readings.
ModPG3 Investigational Device: • Connex Vital Sign Monitor with ModPG3
* Laptop
* Blood Pressure Data Collection Software (not used for test report analysis)
* USB cable
* Power strip
* Welch Allyn FlexiPort Reusable Blood Pressure Cuffs
Auscultatory Equipment: • Reference Sphygmomanometer1
* Reference Cuffs2
* Dual Auscultatory Stethoscope
* Tape measure
* Stopwatch
|
|---|---|
|
Overall Study
STARTED
|
152
|
|
Overall Study
COMPLETED
|
134
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Pressure Readings
n=152 Participants
The study will be conducted in 2 parts.
* Part 1 will test subjects using the ModPG3 Investigational device with the SureBP algorithm enabled.
* Part 2 will test subjects using the ModPG3 Investigational device with the StepBP algorithm enabled.
The study requires three observers. The first two observers take auscultatory readings that are averaged to use as reference blood pressures. The third observer operates the ModPG3 investigational device and records the readings for that device.
The two clinicians taking reference readings will be blinded to each other's readings and to the investigational device readings.
ModPG3 Investigational Device: • Connex Vital Sign Monitor with ModPG3
* Laptop
* Blood Pressure Data Collection Software (not used for test report analysis)
* USB cable
* Power strip
* Welch Allyn FlexiPort Reusable Blood Pressure Cuffs
Auscultatory Equipment: • Reference Sphygmomanometer1
* Reference Cuffs2
* Dual Auscultatory Stethoscope
* Tape measure
* Stopwatch
|
|---|---|
|
Age, Customized
3 - 17 years
|
57 Participants
n=152 Participants
|
|
Age, Customized
>= 18 years
|
95 Participants
n=152 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=152 Participants
|
|
Region of Enrollment
Italy
|
152 participants
n=152 Participants
|
|
Arm Circumference of ≥12-55 cm
|
152 Participants
n=152 Participants
|
PRIMARY outcome
Timeframe: Day 1 (up to 1 hour)Population: The study was terminated due to errors in the algorithm planned for data processing and analysis. A validated post processing algorithm for the raw data files was never finalized, so no blood pressure measurements needed for analysis are available. There is no data available to populate the outcome measure.
BP readings for all subjects will be calculated separately for systolic and diastolic blood pressure. At least three paired blood pressure values shall be taken for each subject. ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
Outcome measures
Outcome data not reported
Adverse Events
Blood Pressure Readings
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place